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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sleeve, limb, compressible
510(k) Number K953850
Device Name REDOX
Applicant
KINETIC CONCEPTS, INC.
P.O. BOX 659508
SAN ANTONIO,  TX  78216 -9508
Applicant Contact WILLIAM H QUIRK
Correspondent
KINETIC CONCEPTS, INC.
P.O. BOX 659508
SAN ANTONIO,  TX  78216 -9508
Correspondent Contact WILLIAM H QUIRK
Regulation Number870.5800
Classification Product Code
JOW  
Date Received08/16/1995
Decision Date 03/04/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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